Qualified Person

Job Opportunity: Qualified Person (QP) for Investigational Medicinal Products (IMPs)Location: Midlands across a couple of factoriesINSIDE IR35 ONLYInterim: 6-12 months, flexible for part time 3-5 days per weekReporting Line: R&D Quality Director HealthAbout the Role:We are seeking a highly skilled and dedicated Qualified Person (QP) for Investigational Medicinal Products (IMPs). This role is crucial for ensuring compliance with various EU and UK regulations, including Directive 2001/83/EC and SI 2012 no. 1916. The successful candidate will be responsible for the GMP certification of IMPs, ensuring that all operations comply with regulatory requirements.Key Responsibilities:

• Regulatory Compliance: Ensure compliance with relevant legislation and guidance impacting IMP manufacturing for clinical trials.
• GMP Certification: Certify IMPs manufactured, ensuring all operations meet regulatory standards.
• Quality Systems: Support the maintenance and implementation of robust Quality Systems to facilitate product release.
• Deviation Management: Document deviations, conduct investigations, and implement corrective and preventive actions (CAPAs).
• Training: Provide training and guidance to trainee QPs and other colleagues as needed.
• Documentation Review: Review Clinical Trials Authorisations and manufacturing documentation for QP batch certification.
• Investigation: Involve in the investigation and reporting of suspect/defective medicinal products and medical devices.

Qualifications:

• Qualified Person Status: Must be qualified according to article 49 of EU directive 2001/83/EC and schedule 7 of SI 2012 no. 1916.
• Experience: Demonstrable experience with solid and liquid dosage forms, including knowledge of manufacturing processes, supply chains, and quality control tests.
• Professional Development: Meet the requirements for continuing professional development to maintain QP status.

Why Join Us?

• Impactful Work: Play a key role in ensuring the safety and efficacy of investigational medicinal products.
• Professional Growth: Opportunities for continuous learning and professional development.
• Collaborative Environment: Work with a diverse team of professionals dedicated to making a difference in the health sector.

If you are a qualified and experienced QP looking for a challenging and rewarding opportunity, we would love to hear from you. Apply now to join our team and contribute to the advancement of clinical trials and medicinal product safety.